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Checkpoint Inhibitor

Atezolizumab + Stereotactic Radiation for Breast Cancer with Brain Tumor

Phase 2
Waitlist Available
Led By Nancy U Lin, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2
Participants must have normal organ and marrow function as defined
Must not have
The participant has an uncontrolled intercurrent illness
Known leptomeningeal or brainstem metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from the first dose of atezolizumab to the date of death from any cause or date last known alive, for a maximum of 3.8 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the combination of atezolizumab and SRS is more effective in treating triple-negative breast cancer that has spread to the brain, than SRS alone.

Who is the study for?
This trial is for adults with triple-negative breast cancer that has spread to the brain. They must have stable brain metastases treatable with SRS, controlled steroid use, measurable disease outside the brain, and normal organ function. Pregnant women or those on high-dose steroids, previous anti-PD-1/PD-L1 therapy, or with certain medical conditions are excluded.
What is being tested?
The study tests combining atezolizumab (a drug) with stereotactic radiosurgery (SRS), a precise radiation procedure for treating brain tumors in patients whose breast cancer has spread to the brain.
What are the potential side effects?
Atezolizumab may cause immune-related reactions like inflammation of organs, infusion reactions similar to allergic responses, fatigue and potential lung issues. SRS can lead to headaches, swelling around the treatment area and temporary hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My organs and bone marrow are functioning normally.
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I do not have more than 5 new brain lesions needing focused radiation.
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My cancer can be measured by scans outside of my brain.
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My cancer is triple-negative.
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I have brain metastases and need stereotactic radiosurgery.
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My brain tumor is clearly defined and no larger than 3.0 cm.
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I am 18 years old or older.
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My side effects from cancer treatment are mild.
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My breast cancer is confirmed to be at stage IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious illness that is not under control.
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My cancer has spread to the brain or its coverings.
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I haven't taken high doses of steroids like dexamethasone (>2mg/day) in the last week.
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I am on long-term steroids or other drugs that weaken my immune system.
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I am being treated with steroids for lung inflammation not caused by an infection.
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I cannot have MRI scans with gadolinium contrast or IV contrast.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I need urgent brain surgery due to complications.
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I have not received a live vaccine in the last 28 days.
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I have a history of lung scarring or fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from the first dose of atezolizumab to the date of death from any cause or date last known alive, for a maximum of 3.8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from the first dose of atezolizumab to the date of death from any cause or date last known alive, for a maximum of 3.8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival
Secondary study objectives
Extracranial Objective Response Rate
Overall Survival

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Dysgeusia
8%
Headache
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atezolizumab + Stereotactic radiosurgery (SRS)Experimental Treatment2 Interventions
* Atezolizumab administered intravenously once every 3 weeks * Stereotactic radiosurgery (SRS) begin within 14 days after brain MRI obtained
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,050 Total Patients Enrolled
96 Trials studying Breast Cancer
23,212 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,875 Total Patients Enrolled
144 Trials studying Breast Cancer
20,199 Patients Enrolled for Breast Cancer
Nancy U Lin, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Breast Cancer
50 Patients Enrolled for Breast Cancer

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03483012 — Phase 2
Breast Cancer Research Study Groups: Atezolizumab + Stereotactic radiosurgery (SRS)
Breast Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03483012 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03483012 — Phase 2
~1 spots leftby Dec 2025
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